City and County of Denver Rules and Regulations for Body Artist, Body Art Establishments, and Mobile Body Art Vehicles Chapter 24 DRMC

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1 City and County of Denver Rules and Regulations for Body Artist, Body Art Establishments, and Mobile Body Art Vehicles Chapter 24 DRMC Adopted by the Board of Environmental Health on March 11, 1999 And Amended Section 5.C.6.f on November 15, 2005 Denver Department of Environmental Health Public Health Inspection Division 201 W Colfax Ave Department 1009 Denver Colorado Fax Authority: The Board of Environmental Health and the Manager of Environmental Health adopts these rules and regulations pursuant to the authority granted by the Charter and Section 24 of the Denver Revised Municipal Code (DRMC) and supplement the provisions of Chapter 24, DRMC

2 Section 1: DEFINITIONS & PURPOSE: A. The purpose of these regulations is to establish sterilization, infection and exposure control and safety standards for the business of body art pursuant to, The Revised Municipal Code, Chapter 24- BODY ART. B. In addition to the definitions contained in Chapter 24- the following term contained in these rules and regulations shall have the following meaning: 1. AFTERCARE means written instructions given to the client, specific to the body art procedure (s) rendered, on caring for the body art and surrounding area. These instructions will include information when to seek medical treatment, if necessary. 2. ANTISEPTIC means a substance that kills bacteria and other microorganisms when applied to the skin (e.g. Chlorohexidine gluconate, alcohol, and iodophor).those should not be used to decontaminate inanimate objects. 3. APPROVED means acceptable to the manager. 4. BLOODBORNE PATHOGENS means disease-causing microorganisms that are present in human blood. These pathogens include, but are not limited to; hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). 5. CONTAMINATED means the presence or reasonably anticipated presence of blood, infectious materials or other types of impure materials that have corrupted a surface or item through contact. 6. CONTAMINATED WASTE means any liquid or semi-liquid blood or other potentially infections materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials that are capable of releasing these materials while handling; sharps and any wastes containing blood and other potentially hazardous materials, as defined in 29 Code of Federal Regulations Part (latest edition), known as Occupational Exposure to Blood borne Pathogens. 7. CROSS-CONTAMINATION means the spread of organisms from a contaminated object or surface to another surface. 8. DISINFECTION means to destruct or inhibit pathogenic microorganisms on inanimate objects or surfaces, thereby rendering these objects safe for use or handling. This is not the same as sterilization. 9. DISINFECTANT means an EPA registered environmental disinfectant proven to be effective against HBV and HIV or a 1:100 dilution of normal strength household bleach and water made fresh daily and dispensed from a spray bottle. 10. INFECTION AND EXPOSURE CONTROL PLAN means a written plan outlining the practices and procedures for the safe operation of a body art establishment. 11. INVASIVE means entry into the body either by incision or insertion of an instrument into or through the skin or mucosa, or by any other means intended to puncture, break, or compromise the skin or mucosa. Page 2 of 11

3 12. JEWELRY means any personal ornament inserted into a newly pierced area, which must be made of surgical implant grade stainless steel; solid 14K or 18K white or yellow gold, niobium, titanium, or platinum; FDA approved F 138 or ISO equivalent ; or a dense, low-porosity plastic which is free of nicks, scratches, or irregular surfaces. 13. PROCEDURE AREA means any surface of an inanimate object that contacts the client s unclothed body during a body art procedure, skin preparation of the area adjacent to and including the body art procedure or any associated work area which may require sanitizing. This definition includes the immediate area where instruments and supplies are placed during a procedure. 14. PRE-STERILIZED means those that are commercially sterilized by the manufacturer. Each package shall have a legible sterilization lot number. 15. REUSEABLE DEVICES means instruments or other items of equipment that are approved by the manufacturer for reuse after appropriate cleaning, decontamination, and sterilization. 16. SHARPS means any object (sterile or contaminated) that may purposely or accidentally cut the skin or mucosa including, but not limited to, pre-sterilized, single use needles, scalpel blades, and razor blades. 17. SHARPS CONTAINER means a puncture-resistant, leak-proof container that can be closed for handling, storage, transportation, and disposal that is labeled with the International Biohazard Symbol. 18. UNIVERSAL (STANDARD) PRECAUTIONS means an approach to infection control that assumes all blood and body substances are treated as if infectious (i.e., capable of causing human disease). 20. STERILIZATION means a process that results in the total destruction of all forms of microbial life, including highly resistant bacterial spores, on reusable equipment and devices SECTION 2: MINIMUM REQUIREMENTS FOR BODY ARTISTS: A. All body artists shall comply with the following: 1. Possess and demonstrate knowledge of universal precautions, health and safety precautions, and disinfection and sterilization techniques. 2. Provide proof of successful completion of a universal precautions course prior to being approved for registration. 3. Universal precautions must be renewed every three years. 4. Prominently display the license, permit, or registration and ID card at any workstation in which she or he practices. 5. Receive the hepatitis B (HBV) vaccination or provide a written statement to the resident manager or owner stating the artist is declining the vaccination. Page 3 of 11

4 SECTION 3: REQUIREMENTS FOR RESIDENT MANAGER/OWNER A. The following information regarding all employees shall be kept on file on the premises of the licensed or permitted establishment or mobile body art vehicle and available for inspection by the department. 1. Full name; 2. Home address; 3. Home phone number; and 4. Proof that all operators or body artists have either completed or were offered and declined, in writing, the hepatitis B vaccination series. B. The following information shall be on the premise for review by the department: 1. Establishment license or permit posted in prominent location; 2. Contract or agreement for sharps disposal; 3. Spore test log and test results; 4. Client records dating back two years; 5. Manufacturer s information on autoclave/sterilization equipment; 6. Written infection and exposure control plan; and C. The facility license or permit holder or operator of any body art establishment shall: 1. Require each individual within the facility providing body art services, to be licensed by the Department of Excise and License prior to employment; and 2. Develop and insure compliance with an infection and exposure control program as specified in section 10. SECTION 4: REPORTING REQUIREMENTS A. All infections, complications or diseases resulting from any body art procedure that become known to the manager/body artist shall be reported to the department by the manager/body artist within 24 hours after discovery. SECTION 5: CUSTOMER RECORDS (Amended on November 15, 2005 ) Page 4 of 11 A. The body art licensee, permit holder and/or local manager shall maintain customer records for a minimum of two years. B. The following information shall be obtained by the body artist from the customer, indicating if the client has had any of the following: 1. Diabetes; 2. Communicable disease; 3. Hemophilia; 4. Skin diseases, skin lesions ; 5. Allergies or adverse reactions to pigments, dyes, disinfectants or soaps; 6. History of epilepsy, seizures, fainting or narcolepsy; 7. Taking anticoagulants or other medications that thin the blood and/or interferes with blood clotting; and 8. Any other information that would aid the manager/body artist in the client s body art healing process evaluation. C. Client consent form shall be obtained prior to all procedures and shall include, but not

5 be limited to, the following: 1. Name, address and current phone number of the client; 2. Date(s) of the procedure 3. The type and location of the body art; 4. Sterilization date or package/lot number used during the procedure; 5. Source/manufacturer and lot number of ink, pigment or dyes if any are used in procedure; and 6. Written and verbal instructions regarding risks; outcome, and aftercare including:; a. Advising the client to consult a physician at the first sign of an adverse reaction (i.e., swelling, infection, illness, allergic reaction or disease); b. Providing the client the name, address and phone number of the establishment and the name of the body artist who performed the procedure; c. Advising the client that tattoos and permanent cosmetics should be considered permanent, that it can only be removed with a surgical or laser procedure and that any effective removal may leave scarring; d. Detailed description to the client of how to care for the body art procedure site; and e. Explanation to the client of the healing process including expected duration, possible side effects, abnormalities, and restrictions or limitations. f. The following written statement: Outside of the normal limits of healing, any concerns that your body art has resulted in complications, infection or disease should be reported to: Denver Department of Environmental Health Public Health Inspection- Body Art 201 W Colfax Ave. Dept 1009 Denver, CO You may also report to your artist any concerns about complications, infections or disease. The rules and regulations governing body art establishments and body artists require that the body artist report those conditions to the Department within 24 hours of discovery. SECTION 6: CONSTRUCTION STANDARDS Page 5 of 11 A. All new, change of use, or remodeling of establishments require department approved plans prior to commencing work and in advance of the application for any building, plumbing, or electrical permits. B. Plans shall indicate the layout of the reception area, the procedure areas, the cleaning and sterilization area, the storage area, and the toilet facilities. C. All construction shall be conducted and completed in accordance with all applicable local codes. SECTION 7: FACILITY AND OPERATIONAL REQUIREMENTS A. All floors, walls and ceilings in procedure areas, instrument cleaning areas and restrooms shall be made of smooth, nonabsorbent, and light colored material that is easily cleanable.

6 B. The premises shall be constructed and maintained clean and in good repair. C. At least fifty foot-candles of artificial light shall be provided at the level where the body art procedure is being performed. At least twenty foot-candles of artificial light shall be available in all other areas. D. All surfaces, including counters, tables, equipment, chairs, recliners, shelving, and cabinets in the procedure areas and instrument cleaning room shall be made of smooth, nonabsorbent materials to allow for easy cleaning and disinfection. E. Hand sinks with hot and cold running water under pressure, supplied with soap and single use paper towels, shall be accessible to the procedure area. Hand sinks shall also be available in toilet rooms. F. Distinct, separate areas shall be provided for cleaning equipment, wrapping/packaging equipment, and for the handling and storage of sterilized equipment. G. An instrument-cleaning sink may be used for hand washing if approved by the department. Sinks used for hand washing, instrument cleaning, or both shall not be used as janitorial sinks. H. The water supply shall be from an approved source. I. Sewage, including liquid wastes, shall be discharged to a sanitary sewer or to a sewage system constructed, operated, and maintained according to law. J. All facilities shall have the waiting area separated from the workstations and the cleaning room or area. A public restroom shall be available to clients during all business hours. K. Reusable cloth items shall be mechanically washed with detergent and dried after each use. The cloth items shall be stored in a dry, clean environment until used. Contaminated laundry shall be stored separate from clean laundry. L. No animals, except service animals, shall be allowed in body art establishments. M. Contaminated waste shall be disposed of separately in appropriately labeled and covered containers. N. All facilities shall have an approved, bio-hazardous labeled sharps container for disposal of sharps that come into contact with contaminated waste. SECTION 8: TEMPORARY/SPECIAL EVENT AND MOBILE BODY ART REQUIREMENTS A. In addition to the requirements listed in Section 6, the following shall apply: 1. Hand wash facilities shall be accessible to each procedure area. Temporary hand wash facilities shall consist of soap, single use paper towels and an adequate supply of warm potable water. Wastewater shall be collected and disposed of in a sanitary manner. 2. Any cleaning of reusable instruments shall be conducted in accordance with Section (11) (B), Instrument cleaning. 3. Body artists may bring pre-sterilized equipment with a spore test log showing a negative result within the previous thirty days, or on site sterilization units may be used and shall comply with Section (11)(D). 4. After the last procedure is completed, all procedure areas shall be cleaned and disinfected. Organic matter shall be removed prior to disinfection of the area. Page 6 of 11

7 SECTION 9: REQUIREMENTS FOR MOBILE BODY ART VEHICLES A. Body art performed pursuant to this section shall be performed from an enclosed vehicle. B. Doors shall be self-closing and tight fitting. Operable windows shall have tight-fitting screens. C. If there is not an on board restroom, the mobile vehicle shall be operated within two hundred feet of a public restroom. D. Mobile body art establishments must receive an initial inspection at a location specified by the department prior to use to ensure compliance with structural requirements. Additional inspections may be performed at any event where the mobile body art establishment is scheduled to operate. E. Mobile vehicles lacking on board cleaning and sterilization equipment shall be associated with an approved permanent facility. Such vehicles shall have on board sufficient instruments, equipment, and supplies to perform procedures. SECTION 10: INFECTION AND EXPOSURE CONTROL WRITTEN PLAN A. Every mobile, temporary or permanent body art establishment shall have and comply with written procedures for infection and exposure control. B. All procedures for the written plan shall be in compliance with Occupational Safety and Health Administration, Centers for Disease Control and Prevention standards, and all local and state regulations. C. These written procedures shall include, but are not limited to: 1. Instrument cleaning and sterilization; 2. Cleaning and disinfection of the procedure areas; 3. Storage and disposal of sharps; 4. Universal precautions procedures; 5. Post exposure procedures; 6. Use of personal protective equipment; 7. Hand washing procedures; 8. Chemical storage and safety; and 9. Injury and illness prevention. SECTION 11: INSTRUMENTS/STERILIZER All non-disposable instruments that penetrate body tissue shall be properly cleaned, packaged or wrapped with a color change indicator, sterilized, and stored appropriately to prevent cross-contamination. All other instruments shall be cleaned and disinfected after each use. Single use items shall not be used on more than one client for any reason. After use, all single use needles, razors and other sharps shall be immediately disposed of in approved sharps containers. Page 7 of 11 A. Sterilizer requirements 1. The sterilizer shall be labeled as a medical instrument sterilizer.

8 Page 8 of Sterilizer must be a steam autoclave. 3. The operator s manual for the sterilizer shall be available on the premise. 4. The sterilizer shall be used, cleaned, and maintained according to manufacturer s specifications. 5. If the body art establishment uses all single- use instruments and products and utilizes sterile supplies a sterilizer shall not be required. B. Instrument Cleaning 1. Used instruments shall be placed in an impervious plastic covered container and soaked in an instrument soaking solution until cleaning can be performed. The solution shall be changed as recommended by the manufacturer. 2. Employees shall wear gloves while cleaning instruments. 3. Instruments shall be properly disassembled for cleaning according to manufacturer s recommendations. 4. All instrument components shall be cleaned either manually or in an ultrasonic cleaner using the appropriate cleaning agent specific to the type of cleaning performed. 5. Organic matter must be removed prior to disinfection. C. Instrument packaging/wrapping 1. Employees shall change into a new pair of gloves before packaging/wrapping instruments. 2. Instruments shall be wrapped. Each package shall be sealed with indicator tape. 3. A chemical indicator shall be contained in or placed inside all packages and must be placed in the area of the pack considered to be least accessible to steam penetration. 4. All packages shall be labeled with the time and date of sterilization. Packages must be dated with an expiration date not to exceed six months. Peel packs may be labeled with an expiration date not to exceed twelve months. D. Instrument sterilization 1. Sterilizers shall be used according to manufacturer s recommendations at appropriate adjustments for altitude. 2. A sterilizer load log shall be maintained for a minimum of two years at the facility and made available for inspection. 3. The log shall contain the following documentation for each load: a. Description of instruments contained in the load. b. Date of sterilization load. c. Sterilizer cycle time(start and stop time) d. Sterilizer temperature. e. Indication of proper sterilization of instruments, as evidenced by the appropriate color and chemical indicator change on each package. f. Action taken when appropriate color change did not occur. g. Name of person who ran sterilizer and name of person who checked outcome. E. Instrument Storage 1. Hands shall be washed prior to handling sterilized instrument packs. 2. After sterilization, the instruments shall be stored in a dry, clean area reserved for storage of sterile instruments.

9 F. Sterilization Monitoring 1. Sterilizer monitoring shall be performed at least monthly (unless otherwise specified by manufacturer) for functionality and thorough sterilization by using a commercial biological monitoring (spore) system to assure all microorganisms, including spores, have been destroyed. 2. A laboratory independent from the establishment shall analyze all biological indicators. 3. The records of analysis shall be maintained on the premises for a minimum of two years. G. Instrument Recall Instrument recall practices shall include but are not limited to the following: 1. In the event of a positive biological indicator result or mechanical failure, all items sterilized since the time of the last negative biological monitor result shall immediately be recalled and prohibited from use until cause of positive biological indicator test result is identified. The sterilizer shall not be used to sterilize instruments until the cause of positive indicator testing is identified. 2. Biological monitor testing shall be repeated and if negative, all recalled items may be used and sterilization may continue. If repeat testing is positive, sterilizer servicing shall be performed. The sterilizer may not be used until sterilizer service is complete and biological indicator testing is negative. 3. If a mechanical failure was identified as evidenced of a repeat positive biological indicator test, the facility shall resterilize all recalled instruments and assess if any items were used since the time of the last negative indicator test. The Department of Environmental Health shall immediately be notified of the mechanical failure. SECTION 12: BODY ART PROCEDURES A. Prohibitions include: 1. There will be no reuse of needles in any procedure. Only single use needles will be used; 2. Procedures may not be performed on any person who is noticeably impaired by drugs or alcohol; 3. No smoking, eating or drinking is allowed in the procedure area or instrument cleaning room; and 4. No body art procedure shall be performed on the skin surfaces, which have sunburn, rash, pustules, boils, infections, and moles, jaundice or manifest any evidence of unhealthy conditions. B. The following procedures must be practiced by all body artists: 1. Thoroughly wash hands and forearms with soap and warm water before and after serving each client. Following thorough washing, hands shall be dried using clean, single use paper towels; 2. Wear new, clean, disposable examination gloves for every client during the procedure. If a glove is pierced, torn or contaminated, both gloves must be properly removed and discarded. Hands shall be washed prior to donning a new pair of disposable gloves; Page 9 of 11

10 3. Drapes, lap cloths, or aprons shall be used and changed between each client; 4. Wearing new disposal examination gloves, the body artist shall assemble, to prevent contamination, instruments and supplies to be used in the procedure. All sterilized instruments shall remain in the sterile packages until opened in front of the client; 5. All substances used in the procedures shall be dispensed from containers in a manner to prevent contamination of the unused portion; 6. Single use ointment tubes, applicators and supplies shall be discarded after the procedure; 7. If spray bottles are used to dispense liquids, the liquid shall be sprayed onto a single use wipe rather than directly onto the client; and 8. The procedure area and equipment or supplies touched during the procedure shall be wiped down with a disinfectant using single use paper towels after each client. C. Procedures specific to tattooing. 1. The use of hectographic or single-service tissue stencils shall be required for applying a tattoo outline to the skin, except that, when the design is drawn free hand, single use non-toxic markers or other devices shall be used. The use of acetate or other multi use stencils is prohibited. 2. Inks, dyes or pigments in single-use containers shall be used for each client. Any remaining unused dye or pigment shall be discarded immediately following the tattoo procedure. 3. If inks, dyes or pigments are prepared by the body artist a list of ingredients and the procedure used in the production must be on file for review by the inspector. 4. Before placing the design on the skin, the body artist shall clean any area other than the face with germicidal soap, and if necessary, shave off any hair with a disposable, single-use safety razor, then apply the stencil. 5. The area shall be cleaned during and after the procedure with an antiseptic solution. 6. The stencil shall be applied with the antiseptic cleaner or other approved product dispensed from a container in a manner that does not contaminate the unused portion. 7. Excess ink, dye or pigment applied to the skin during tattooing, shall be removed with a clean single-use paper product. 8. After the procedure is completed, the area shall be covered with clean dressing and held in place with a suitable skin tape. Page 10 of 11 D. Procedures specific to body piercing. 1. All body piercing needles shall be single use, sterilized disposable surgical piercing needles and disposed of immediately after use in a sharps container. 2. Only sterilized or high level disinfected jewelry meeting the definition found in section 1 (B) (12) of these regulations, in new or good condition shall be used for piercing.

11 These rules were approved for publication by the Board of Environmental Health at the regular board meeting of January 14, These rules were adopted by the Board of Environmental Health after a public rule making hearing during the regular board meeting of March 11, Page 11 of 11